A phase II, multicentre, open-label, single arm, extension study of maintenancetreatment with subcutaneous homoharringtonine (HHT) as a single agent inpatients with chronic myeloid leukemia (CML) who received HHT in study HHT-CML/INTL/04.2 and have achieved a complete hematological response (CHR)or returned to chronic phase.

STRAGEN France0 sites60 target enrollmentSeptember 14, 2005

Overview

No summary available.

Registry

who.int

Start Date

September 14, 2005

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•a) Male or female patients aged 18 to 80 years.
•b) Patients who participated to protocol HHT\-CML/INTL/04\.2 and who have either achieved a Complete Hematological Response or returned to chronic phase of CML after one or two courses of subcutaneous HHT.
•c) Estimated life expectancy of at least 12 weeks.
•d) Adequate performance status as defined by a grading of 2 or better on the ECOG
•Performance Status Criteria.
•e) Female patients of child\-bearing potential willing to use adequate contraception (oral contraceptive pill, IUD, surgical sterilisation, contraceptive patches, depot injection or barrier method in combination with a spermicide) for the duration of and at least one month after the last dose of investigational product.
•f) Male patients willing to use adequate contraception for the duration of and at least three months after the last dose of investigational product.
•g) Patients who have given written informed consent after having read and understood the patient information sheet.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:

•a)Patients who did not achieve CHR or return to Chronic Phase of CML while treated with subcutaneous HHT in protocol HHT\-CML/INTL/04\.2\.
•b) Primary resistance to HHT.
•c) Reappearance of hematological features consistent with accelerated phase or progression to blastic phase of CML.
•d) Ongoing grade 3\-4 hematological toxicity related.
•e) Patients who need to receive anti\-leukemic agents other than HHT, hydroxyurea (HU) or anagrelide during the trial.
•f) Female patients who are pregnant (confirmed by a serum pregnancy test) or lactating.
•g) NYHA class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
•h) Creatinine levels more than 3 x ULN (upper limit of normal range) at the laboratory where the analysis was performed.
•i) Total serum bilirubin more than 3 x ULN in patients without clinically suspected leukemia involvement of the liver.
•j) AST (SGOT) or ALT (SGPT) more than 5 x ULN in patients without clinically suspected